Clinical Study of Repeated Transcranial Magnetic Stimulation(rTMS) for Chronic Visceral Pain in Patients With Irritable Bowel Syndrome(IBS)

2024156

Objective: To evaluate the overall efficacy of rTMS in the treatment of irritable bowel syndrome and to explore the central mechanism of rTMS for IBS. Methods: 1. Clinical efficacy evaluation of TMS for chronic visceral pain in IBS patients The 200 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS and Western medicine group. Corresponding treatment was given for 1 week, rTMS group received 1 Hz/s, 20 min for 1 week; Western medicine group received pivinonium tablets orally, 50 mg three times a day for 1 week. Clinical assessment included symptoms, stool traits, mood, and sleep. 2. Study on the central mechanism of using fMRI to treat chronic visceral pain in IBS patients Forty cases each were included in the IBS-eligible patient group and the healthy control group, and repeated transcranial magnetic stimulation treatment was given to the patient group for 1 week, and the patient group underwent the assessment of clinical observational indexes (IBS-SSS, SAS, SDS, and AIS) before and after the treatment and the acquisition of functional magnetic resonance data. In the healthy control group, clinical observation indexes (SAS, SDS, AIS) were evaluated before enrollment, and functional magnetic resonance data were collected after enrollment. Conclusion: 1. The clinical efficacy of rTMS for IBS is superior to that of the western drug pivoxyl bromide tablets. 2. Targeted brain areas of rTMS treatment: there was a positive correlation between the change in ALFF values of mPFC and the improvement in abdominal pain level score before and after treatment.

2024-04-01

2026-01-30

2026-01-30

Recruiting

Early phase I

200

Inclusion Criteria: 1. Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV. 2. Age range between 18-70 years. 3. The duration of the disease is more than 6 months. 4. There are no pathologic abnormalities or biochemical changes that could explain the bowel-related symptoms. 5. The IBS symptom severity score at baseline must not be less than 75. 6. No pharmacological treatment (excluding emergency treatment) for IBS for at least 2 weeks prior to the start of treatment; no concurrent participation in other clinical programs. 7. Voluntarily sign the relevant informed consent form and voluntarily participate in this clinical project. Exclusion Criteria: 1. Be less than 18 years old or more than 70 years old. 2. Those who suffer from severe liver, kidney, hematopoietic system diseases, cardiovascular and cerebrovascular diseases, and psychiatric diseases that significantly affect cognitive function. 3. Patients with clear organic diseases of the intestinal tract; patients with diabetes, hyperthyroidism and other systemic diseases that affect the digestive tract dynamics; patients who have had a history of surgery on the anus and intestines or the abdomen. 4. The presence of the following conditions affecting the efficacy or safety judgment: ① regular use of preparations and drugs affecting gastrointestinal dynamics or function; ② treatment with other treatments and drugs that may affect the results of the judgment. 5. Those who are pregnant, breastfeeding or less than 12 months after delivery. 6. Patients with severe fear of needles, metal allergies or sensitivities, or those with pacemakers. 7. Patients who do not comply with the randomized assignment to the treatment group or have a tendency to be unstable such as poor compliance. 8. Patients who are participating in other research projects. 9. Those who do not want to sign the informed consent form.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-05-14